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市場調查報告書
商品編碼
1476429
藥物有效成分的全球市場預測(~2030):按藥物類型、製造商類型、API類型、應用、最終用戶和地區的分析Active Pharmaceutical Ingredients Market Forecasts to 2030 - Global Analysis By Drug Type, Manufacturer Type, API Type, Application, End User and by Geography |
2023年全球藥物有效成分市場規模為1,637.5億美元,預估預測期間內年複合成長率為10.2%,至2030年達到3,231.9億美元。藥物中提供所需治療效果的基本成分稱為藥物有效成分(API)。
這些化學物質在用於藥物配方之前經過嚴格的測試並獲得政府核准。 API 有多種過程,例如發酵、自然資源分離和合成。 API 效力、穩定性和純度對於確保最終藥品的安全性和有效性非常重要。
根據世界衛生組織(WHO)的說法,獲得基本藥物,包括藥物有效成分(API)是一項基本人權,對於實現可達到的最高健康標準非常重要。
處方藥的需求不斷成長
隨著品牌藥的專利到期,學名藥公司有機會以更便宜的替代品進入市場。學名藥為患者和醫療保健系統節省了大量成本,推動了它們的普及。美國簡化新藥認證申請(ANDA)等監管核准途徑允許學名藥進入市場。此外,隨著醫療保健支付者和提供者實施學名藥替代政策,負擔得起的學名藥的可用性將鼓勵它們的使用。
價格下降和成本限制
由於製藥業(尤其是學名藥領域)的激烈競爭,原料藥製造商經常面臨利潤壓力和價格下降。由於買家和賣家之間的價格競爭、行業整合以及政府控制醫療保健成本的計劃,價格呈下降趨勢。此外,為了在價格壓力下保持獲利,原料藥製造商必須不斷改善業務、提高效率並考慮降低成本的方法。
個性化醫療的成長
API 製造商可以從個人化醫療策略中受益匪淺,這些策略的重點是根據每個患者的獨特需求量身定做護理。基因組序列測定、生物標記識別和資料分析的進步使得開發更有效且副作用更少的標靶治療成為可能。此外,個人化醫療應用可以採用標靶治療治療、基因編輯技術和伴同性診斷作為 API。 API 製造商可以與製藥、診斷和醫療機構合作開發和生產客製化醫療產品。
激烈的競爭和價格壓力
國內外原料藥製造業競爭十分激烈。製造商之間爭奪市場佔有率的競爭壓縮利潤並降低價格。這種壓力在主要由價格競爭驅動的非專利藥市場尤其嚴重。此外,人事費用和生產成本較低的地區存在低成本製造商,這加劇了競爭,使企業難以持續成長和保持獲利。
COVID-19 大流行對藥品供應鏈造成了重大干擾,對 API 市場產生了重大影響。封鎖措施、旅行限制和勞動力短缺擾亂了製造業務,導致生產延誤和供應鏈瓶頸。對類固醇、抗生素和抗病毒藥物等重要藥物的需求日益增加。這給供應鏈帶來了壓力,並加劇了成品藥和關鍵原料藥的短缺。此外,製藥業者還面臨疫情帶來的不確定性,原物料保障、產品運輸、業務永續營運都面臨困難。
品牌和處方新藥市場預計將在預測期內成為最大的市場
在藥物有效成分(API)市場中,品牌和處方新藥領域預計將佔最大佔有率。品牌處方藥通常需要獨特且專有的 API,導致對新型化合物和複雜合成程序的高需求。這些藥物具有高市場價值和市場佔有率的原因之一是它們在上市前通常要經過漫長的臨床試驗、監管核准程序和研發。此外,製藥公司大力投資開發新治療方法,以填補醫療領域的空白,並使自己與競爭對手區分開來。
腫瘤學領域預計在預測期內年複合成長率最高
藥物有效成分(API)市場預計將在腫瘤學領域擁有最高的年複合成長率。由於全球癌症發生率不斷上升以及新癌症治療方法的不斷開發,腫瘤學領域對 API 的需求量很大。用於治療固體癌和骨髓惡性腫瘤的原料藥屬於腫瘤學類別。此外,由於分子生物學、標靶治療和免疫治療的進步,依賴特定 API 的新型癌症治療方法開發中。
藥物有效成分(API)市場預計將佔據北美地區的最大佔有率。許多因素促成了該地區的主導地位,包括強大的製藥業、大量的研發投資、先進的製造基礎設施以及嚴格的監管要求。此外,由於擁有頂級製藥公司、受託製造廠商(CMO)和 API 製造商,北美成為市場領導者。該地區大量的患者人數、高額的醫療保健支出和有利的償付政策進一步推動了對處方藥中使用的原料藥的需求。
醫藥原料藥(API)市場預計將在歐洲擁有最高的年複合成長率。強大的法律規範、先進的製造能力和完善的製藥工業是推動歐洲原料藥市場成長的一些因素。該地區受益於強大的研發生態系統,可培養創造力並促進依賴專門 API 的尖端藥物治療的創建。此外,歐洲對負擔得起且可及的醫療保健的重視以及對學名藥不斷成長的需求也推動了 API 市場的成長。
According to Stratistics MRC, the Global Active Pharmaceutical Ingredients Market is accounted for $163.75 billion in 2023 and is expected to reach $323.19 billion by 2030 growing at a CAGR of 10.2% during the forecast period. The essential elements of pharmaceuticals that result in the desired therapeutic effect are known as active pharmaceutical ingredients, or APIs. These chemicals go through rigorous testing and are approved by the government before being used in pharmaceutical formulations. APIs can come from a range of processes, such as fermentation, natural resource isolation, or synthetic processes. Their potency, stability, and purity are essential for guaranteeing the final drug product's safety and effectiveness.
According to the World Health Organization (WHO), access to essential medicines, including Active Pharmaceutical Ingredients (APIs), is a fundamental human right, essential for achieving the highest attainable standard of health.
Growing need for prescription drugs
Generic pharmaceutical companies are seeing an opening to enter the market with less expensive alternatives as a result of branded drug patents expiring. The substantial cost savings that generic medications provide to patients and healthcare systems encourage their widespread use. Generic versions of previously patented drugs are being allowed to enter the market thanks to regulatory pathways for approval, such as the US Abbreviated New Drug Applications (ANDAs). Furthermore, when affordable generic substitutes are available, the use of them is encouraged by generic drug substitution policies put in place by healthcare payers and providers.
Price decline and cost constraints
API manufacturers frequently face margin pressure and price erosion as a result of the fierce competition in the pharmaceutical industry, especially in the generic drug segment. Prices are trending lower as a result of price competition between buyers and sellers, industry consolidation, and government programs to control healthcare costs. Additionally, in order to stay profitable in the face of price pressure, API manufacturers need to constantly improve their operations, increase efficiency, and look into ways to cut costs.
Growth of customized health care
API producers can greatly benefit from personalized medicine strategies, which center on adjusting medical care to the unique needs of each patient. The development of more effective and less side-effect-prone targeted therapies is made possible by developments in genomic sequencing, biomarker identification, and data analytics. Furthermore, personalized medicine applications may employ targeted therapeutics, gene editing technologies, and companion diagnostics as APIs. To create and produce customized medical products, API manufacturers can work with pharmaceutical, diagnostic, and healthcare organizations.
Strong rivalry and pricing pressure
There is fierce competition in the API manufacturing sector, both nationally and internationally. As a result of competition among manufacturers for market share, margins are compressed and prices are eroded. In the generic API market, where businesses mainly compete on price, this pressure is especially intense. Moreover, the existence of low-cost manufacturers in areas with cheaper labor and production costs heightens competition, making it difficult for businesses to continue growing and remaining profitable.
The COVID-19 pandemic has caused significant disruptions in the pharmaceutical supply chain and has had a significant effect on the API market. Production delays and supply chain bottlenecks have resulted from disruptions in manufacturing operations caused by lockdown measures, travel restrictions, and workforce shortages. The demand for vital drugs, like steroids, antibiotics, and antivirals, has increased. This has put pressure on supply chains and made shortages of finished dosage forms and vital APIs worse. Additionally, pharmaceutical companies have encountered difficulties in locating raw materials, shipping products, and preserving business continuity in the face of uncertainties brought on by pandemics.
The Branded or Innovative Prescription Drugs segment is expected to be the largest during the forecast period
In the Active Pharmaceutical Ingredients (API) market, the branded or innovative prescription drug segment is projected to hold the largest share. Novel compounds and intricate synthesis procedures are in high demand since branded prescription medications frequently need unique and proprietary APIs. One reason for these medications' higher market value and share is that they usually go through lengthy clinical trials, regulatory approval procedures, and research and development before going on sale. Furthermore, to fill gaps in the medical field and set themselves apart from competitors, pharmaceutical companies heavily invest in the development of novel therapies.
The Oncology segment is expected to have the highest CAGR during the forecast period
It is projected that the market for active pharmaceutical ingredients (APIs) will have the highest CAGR in the oncology segment. Due to the rising global incidence of cancer and the ongoing development of novel cancer therapies, oncology APIs are in high demand. The APIs utilized in the treatment of solid tumors and hematologic malignancies fall under the category of oncology. Moreover, novel cancer treatments that rely on specific APIs have been developed as a result of advancements in molecular biology, targeted therapies, and immunotherapy.
It is projected that the market for active pharmaceutical ingredients (APIs) will hold the largest share in the North American region. Many factors contribute to this region's dominance, such as a strong pharmaceutical industry, large investments in R&D, sophisticated manufacturing infrastructure, and strict regulatory requirements. Additionally, North America is the market leader due in part to the existence of top pharmaceutical companies, contract manufacturing organizations (CMOs), and API manufacturers. Demand for APIs used in prescription medications is further driven by the region's large patient population, high healthcare expenditures, and advantageous reimbursement policies.
It is anticipated that the market for active pharmaceutical ingredients (APIs) will grow at the highest CAGR in Europe. A robust regulatory framework, sophisticated manufacturing capabilities, and a well-established pharmaceutical industry are some of the factors propelling the growth of the API market in Europe. The area gains from a strong ecosystem for research and development, which promotes creativity and the creation of cutting-edge medication treatments that depend on specialized APIs. Furthermore, the emphasis Europe has placed on affordable and accessible healthcare, along with the growing need for generic drugs, all support the growth of the API market.
Key players in the market
Some of the key players in Active Pharmaceutical Ingredients market include BASF SE, Dr. Reddy's Laboratories Ltd, Cambrex Corporation, Abbott, Cipla Inc., GlaxoSmithKline plc, Amgen Inc., Merck & Co., Inc., AbbVie, Inc., Mylan N.V., Bausch Health Companies Inc., Eli Lilly and Company, Biocon Ltd., Johnson & Johnson Private Limited, AstraZeneca, Takeda Pharmaceutical Company Limited, Novartis AG, Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd and Pfizer, Inc.
In April 2024, BASF signed a 25-year power purchase agreement (PPA) with China Energy Engineering Group Guangdong Electric Power Design Institute Co., Ltd. (GEDI) to purchase renewable electricity for its Zhanjiang Verbund site. The PPA is a further step in the renewable energy partnership between BASF and GEDI following the Letter of Intent (LOI).
In March 2024, Dr. Reddy's Laboratories said that it has entered into a license agreement with Pharmazz Inc. to commercialise the first-in-class innovative drug Centhaquine in India. Pharmazz is a U.S. based biopharmaceutical company developing and commercializing drug products to treat critically ill patients.
In September 2023, Abbott has entered a definitive agreement for the acquisition of Bigfoot Biomedical, which develops smart insulin management systems for individuals with diabetes. Together, the companies have worked on connected diabetes solutions since 2017.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.